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An international coalition of more than 80 pharmaceutical companies and trade organizations is calling on various governments to collaborate with industry to stamp out drug-resistant infections. Read More
CDER Director Janet Woodcock sees PDUFA reauthorization and beefing up staffing as two top priorities that will occupy much of the FDA’s time over the next year. Read More
Six compounders are suing Express Scripts, accusing the nation’s largest PBM of participating in a massive conspiracy to put independent compounders out of business. Read More
GlaxoSmithKline said it plans to improve its data protection policies in the wake of a federal indictment in Philadelphia this week accusing two former researchers of plotting to steal trade secrets for possible sale to China. Read More
The FDA said Wednesday that its Center for Drug Evaluation and Research and the Office of Prescription Drug Promotion issued 47 warning letters last year, compared with 52 in 2014. Read More
An obesity candidate linked to patient deaths during a clinical trial last year may have a potential path forward after its sponsor revealed that it met its co-primary endpoints in a Phase 3 study. Read More
The FDA’s chief watchdog for drug promotion — the Office of Prescription Drug Promotion — issued its first untitled letter of the year, blasting Hospira for running an online video that omitted multiple required disclosures. Read More